When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Change to Section 3 – removal of Pfizer in debossing on tablets
Included the following two new sub-headings:
2.1 General description
2.2 Qualitative and quantitative composition
4.1 Therapeutic indications
4.2 Posology and method of administration
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
5.1 Pharmacodynamic properties
Minor editorial changes; addition of hyphenation of terms such as treatment-experienced, treatment-naïve, co-administration.
4.8 Undesirable effects
· Minor editorial changes; addition of hyphenation of terms such as treatment-experienced, treatment-naïve, co-administration. · ‘NB’ replaced the asterix * as emphasis on the note at the end of Table 3, to read: N.B. Adverse reactions captured in table 3 were assessed as possibly related to study drug by investigators · Added the full term for OBT at the end of Table 4, ro read:OBT: Optimised Background Therapy
· ‘NB’ replaced the asterix * as emphasis on the note at the end of Table 3, to read: N.B. Adverse reactions captured in table 3 were assessed as possibly related to study drug by investigators · Added the full term for OBT at the end of Table 4, ro read:OBT: Optimised Background Therapy
N.B. Adverse reactions captured in table 3 were assessed as possibly related to study drug by investigators
· Added the full term for OBT at the end of Table 4, ro read:OBT: Optimised Background Therapy
Section 4.4 Special warnings and precautions for use
Updated the warning regarding Cardiovascular safety to add the following statements:
In the pivotal studies of treatment experienced patients (MOTIVATE) coronary heart disease events was more common in patients treated with CELSENTRI than with placebo (11 during 609 PY vs 0 during 111 PY of follow-up). In treatment naïve patients (MERIT) such events occurred at a similarly low rate with CELSENTRI and control (efavirenz). When CELSENTRI was administered to healthy volunteers at doses higher than the recommended dose, cases of symptomatic postural hypotension were seen at a greater frequency than with placebo. However, when CELSENTRI was given at the recommended dose in HIV infected patients in Phase 3 studies, postural hypotension was seen at a similar rate compared to placebo/comparator. Caution should be used when administering CELSENTRI in patients with a history of postural hypotension or on concomitant medicinal products known to lower blood pressure. Updated the warning regarding Hepatic safety with the following statement: Hepatobiliary disorders reported in treatment naïve patients were uncommon and balanced between treatment groups (see section 4.8). Section4.5 Interaction with other medicinal products and other forms of interaction In Table 2 Interactions and dose recommendations with other medical products, regarding Etravirine and darunavir/ritonavir (maraviroc 150 mg BID), a minor editorial change to include the word ‘with’ in the recommendation, i.e.: CELSENTRI dose should be decreased to 150 mg twice daily when co-administered with etravirine and PI (except fosamprenavir/ritonavir where the dose should be 300 mg twice daily) Section 4.6 Fertility, pregnancy and lactation Updated the heading to include Fertility. Section 4.8 Undesirable effects Updated following the review of data from Phase 2b/3 clinical trials (MOTIVATE 1 and MOTIVATE 2) and one study in treatment naïve adult patients (MERIT) infected with CCR5-tropic HIV-1. Section 5.1 Pharmacodynamic properties Updated link to EMA website to: http://www.ema.europa.eu/htms/human/epar/eparintro Section 7 MARKETING AUTHORISATION HOLDER Changed from Pfizer to: ViiV Healthcare UK Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom
When CELSENTRI was administered to healthy volunteers at doses higher than the recommended dose, cases of symptomatic postural hypotension were seen at a greater frequency than with placebo. However, when CELSENTRI was given at the recommended dose in HIV infected patients in Phase 3 studies, postural hypotension was seen at a similar rate compared to placebo/comparator. Caution should be used when administering CELSENTRI in patients with a history of postural hypotension or on concomitant medicinal products known to lower blood pressure. Updated the warning regarding Hepatic safety with the following statement: Hepatobiliary disorders reported in treatment naïve patients were uncommon and balanced between treatment groups (see section 4.8). Section4.5 Interaction with other medicinal products and other forms of interaction In Table 2 Interactions and dose recommendations with other medical products, regarding Etravirine and darunavir/ritonavir (maraviroc 150 mg BID), a minor editorial change to include the word ‘with’ in the recommendation, i.e.: CELSENTRI dose should be decreased to 150 mg twice daily when co-administered with etravirine and PI (except fosamprenavir/ritonavir where the dose should be 300 mg twice daily) Section 4.6 Fertility, pregnancy and lactation Updated the heading to include Fertility. Section 4.8 Undesirable effects Updated following the review of data from Phase 2b/3 clinical trials (MOTIVATE 1 and MOTIVATE 2) and one study in treatment naïve adult patients (MERIT) infected with CCR5-tropic HIV-1. Section 5.1 Pharmacodynamic properties Updated link to EMA website to: http://www.ema.europa.eu/htms/human/epar/eparintro Section 7 MARKETING AUTHORISATION HOLDER Changed from Pfizer to: ViiV Healthcare UK Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom
Updated the warning regarding Hepatic safety with the following statement:
Hepatobiliary disorders reported in treatment naïve patients were uncommon and balanced between treatment groups (see section 4.8).
Section4.5 Interaction with other medicinal products and other forms of interaction
In Table 2 Interactions and dose recommendations with other medical products, regarding Etravirine and darunavir/ritonavir (maraviroc 150 mg BID), a minor editorial change to include the word ‘with’ in the recommendation, i.e.:
CELSENTRI dose should be decreased to 150 mg twice daily when co-administered with etravirine and PI (except fosamprenavir/ritonavir where the dose should be 300 mg twice daily)
Section 4.6 Fertility, pregnancy and lactation
Updated the heading to include Fertility.
Section 4.8 Undesirable effects
Updated following the review of data from Phase 2b/3 clinical trials (MOTIVATE 1 and MOTIVATE 2) and one study in treatment naïve adult patients (MERIT) infected with CCR5-tropic HIV-1.
Section 5.1 Pharmacodynamic properties
Updated link to EMA website to:
http://www.ema.europa.eu/htms/human/epar/eparintro
Changed from Pfizer to:
ViiV Healthcare UK Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom